Saliva sample collection systems

ABSTRACT

Saliva sample collection systems are configured with special attention to ease-of-use for the unskilled user and safe transport and delivery by a conventional delivery services such as Federal Express. A sealed cavity is formed by tight coupling of two primary elements: a receiving vessel element and a sealing cap element. The receiving vessel has integrated therewith: a standing means, a fill-line window, a funnel system, a knife, a threadset, and containment tube among others. A complementary cap element includes a cooperating threadset, label receiving surface, gripping surface, seal means and reservoir with piercable thin-film membrane. These two primary elements may be accommodated in an application-specific shipping container which support two shipping modes whereby the system may be shipped safely to and from a donor user each way in a different shipping mode.

BACKGROUND OF THE INVENTIONS

1. Field

The following invention disclosure is generally concerned with kits andsystems for collection of biological matter and more specificallyconcerned with saliva collection, storage and transmission systemsconfigured for non-expert use.

2. Prior Art

Container arts and engineering presently enjoys an advanced statewhereby container design and function is configured for particularpurpose. For example, and orange juice container made from cardboard mayhave incorporated features therein specifically designed for the acidicnature of orange juice which is quite different from attributes ofsimilar cardboard containers designed for milk for example. In eachcase, particulars relating to shelf life, exposure to UV damage, pulpcontent, in example, affects design of a high-performance containersystem having a specific application.

Containers designed for nonfood applications also are highly advancedwith many incorporated features designed to cooperate with the nature ofthe service for which it is designed. This is particularly true forcontainers designed to collect biological material and even moreparticularly when those containers are to be used without assistancefrom experts—i.e. for use by untrained consumers in a setting whereprofessionals may not be present. Further such containers must sometimessupport special features for long-term storage, durability, safehandling, transmission via postal and delivery services, among others.

In some special cases, it is desirable to provide a container suitablefor safe transmission of biological matter via the mails and privatedelivery services. For example, packages may be arranged with a viewtowards use with private delivery systems and services such as thoseprovided by Federal Express company. In this regard, a package systemmust be provided to protect against shock, temperature changes,duration, et cetera—those attributes associated with the normalprocedures used by delivery service companies. It is further desirablethat containers are designed for ease of use by non experts without needfor special training—and without complex instructions and procedures. Incertain applications, containers for collection of biological samplesare to be used by a donor without assistance of experts or medicalprofessional. In home collection systems, the container must be highlyfunctional without complex instructions and further it must be devoid offailure mechanisms which tend to render collection of a sampledefective. Thus, containers which effectively capture a sample with aminimal amount of steps and a minimal number of parts is a great benefitwith respect to system success.

A number of systems have been developed for handling viscous liquids,particularly saliva and blood serum. See, for example, Haldopoulos, U.S.Pat. No. 3,832,141; Ohringer, U.S. Pat. No. 3,846,077; Breno, U.S. Pat.No. 4,209,488; Mar, U.S. Pat. No. 4,644,807; Romer, U.S. Pat. No.4,895,808; and Seymore, U.S. Pat. No. 5,268,148. However, thoseapparatus that have previously been developed in this field aregenerally sophisticated devices intended for use by a skilled laboratorytechnician.

D'Angelo teaches in U.S. Pat. No. 7,387,999 dated Jun. 17, 2008 a salivasample collection system. A sponge portion is used to swap saliva andsaliva is thereafter extracted from the sponge by squeezing orcentrifuge.

In a disclosure entitled “Apparatus for Sampling, Storing, Preservingand Testing a Specimen”, inventor Alley of Pennsylvania presents a swabtip and cooperating container system which is arranged to compress theswap when inserted therein. A portion of the sample is conveyed into aplurality of separate chambers provided to isolate each from the others.As the kit is designed around multipurpose functions related to testingdirectly within the device, the complexity is significant. Inapplications where only a single sample is required, or systems wheretesting is done wholly external to the sample collection kit, thissystem does not provide advantage.

In U.S. Pat. No. 5,981,293, a full description for a fluid collectionkit and method is published. Biex Inc, of California as assignee uses afluid collection, filtration and storage device in connection withbiological matters such as saliva, among others. In particular, thedevice has a first tube with a closed first end and open second end, anda second concentric tube acting in concert therewith. Also, the systemdeploys a cap to form a liquid tight seal at the outer tube orifice.

Inventors Chess et al, present their invention in U.S. Pat. No.5,674,456 of Oct. 7, 1997. A container with specific design directed toa ‘transportable container’ for a medical specimen—takes the design of a‘Coplin’ jar. “A lid hingedly coupled to the top of the jar”accommodates both ‘open’ and ‘closed’ positions. Included in thesesystems is a tray which receives the container in a “sideways fashion”.However, this tray does not support a dual-mode accommodation for thejar.

Minnesota inventors Lenmark Sr. and Koentopp teach a specialized kitparticularly suited for shipping transport. The container provides for afoam member with prescribed cut-outs to receive sample containing vialstherein. While these cut-outs are not designed in support of anydual-mode shipping objectives, they do indeed accompany a plurality ofelements in an application specific shipping box.

One kit manufactured by DNA Genotech Co. of Ontario, Canada is quitewidely used by many professionals of the DNA diagnostics industries.However these systems have many complexities and shortcomings whichcontribute to failure mechanisms resulting in a unreliable system. Afirst important shortcoming of the Genotech system is that it iscomprised of four discrete parts which must repeatedly be coupled anddecoupled in a series of complex steps which must be executed in aparticular order. While the kit includes a detailed instruction bookletin six languages with a series of grayscale photo-like diagrams, thesteps illustrated are difficult to execute without error for some users.

In one important example, a receiving vessel is coupled by way of athread set to a funnel element. The funnel is provided so that a usercan easily spit into the device and the received saliva will be conveyedinto the small aperture of the receiving vessel. After a sufficientquantity of saliva is received into the vessel, the funnel must bedecoupled from the receiving vessel by twisting the funnel about an axisin a rotational direction opposite to that of which the vessel istwisted. However, this must be done only after a special DNA preservingand stabilizing fluid is introduced to the receiving vessel. To effectthis, another thread set system is coupled to the funnel at an opposingend. That is, at the large end of the funnel, a specifically preparedcontainer of fluid is screwed onto the funnel at its top. As thecontainer is applied in this way, a membrane is pierced and fluidreleased into the funnel through which it passes and finally receivedinto the receiving vessel to mix with the saliva. Then, the funnel maybe finally decoupled from the receiving vessel. Thereafter, a stoppercap with a thread set identical to that of the funnel's narrow end isscrewed onto the vessel aperture end to form a seal thereby trapping andcontaining both collected saliva and stabilization fluid therein.

The funnel and large cap/container are left as waste material. Thereservoir contains residue chemicals which tend to cause anxiety in somepersons. While it is not necessary to discard these pieces as medicalwaste, these leftover parts tend to at least have the appearance ofmedical waste and thus give rise to worry and a need for special andsometimes expensive treatment. It is surely preferable to devise asystem with no leftover parts to be discarder as medical waste. Becausethe funnel needs to be coupled to and decoupled from the receivingvessel, it is formed with integrated finger grips which are easilyengaged and ergonomically cooperative with human finger tips. However ifthe requirement that the funnel be screwed ‘on’ and ‘off’ the receivingvessel were removed, then so would the need for these finger grips; thussimplifying manufacturing processes and saving material. Anotherimportant problem with the collection systems described relates tospilling. Because a considerable amount of saliva is required toproperly fill the receiving vessel, it generally takes a user some timeto provide this quantity. During the process of filling the container,one may wish to set it down while time passes for additional saliva toform in the mouth. However, due to another design shortcoming, thedevice must continuously be held and cannot easily be put down withoutspilling its contents. It would be yet another important improvement ifthe container could rest on its own structure to allow a user time tofill the apparatus without having to continuously hold the device.

While systems and inventions of the art are designed to achieveparticular goals and objectives, some of those being no less thanremarkable, inventions of the art have limitations which prevent uses innew ways now possible. Inventions of the art are not used and cannot beused to realize the advantages and objectives of the invention taughtherefollowing.

SUMMARY OF THE INVENTION

Comes now, James Plante, David Becker, Kathryn J. Elliott, and EdgarMacBean with an invention of saliva sample collection systems includingdevices particularly configured for ease-of-use by unskilled users andfurther configured for safe conveyance via standard shipping services.It is a primary function of these systems to provide easy-to-use salivasample collection kits for direct-to-consumer use. It is a contrast toprior art that systems first taught and presented here do not requirespecial training or skill to effectively use.

An apparatus for saliva sample collection, temporary storage andconveyance via delivery services is formed of two primary elements—eachof these two elements having a plurality of features integratedtherewith. Preferably formed of plastic in molding processes, these twoelements cooperate together to provide ‘coupled’ and ‘decoupled’ states.A receiving vessel and sealing cap which couple together in bestversions via mechanical interlock, in example a thread set typecoupling, form a liquid tight containment cavity suitable for long-termand durable storage of a DNA in a saliva sample.

A receiving vessel may be provided include an integrated funnel portionwhich allows ergonomic cooperation with the human mouth with regard tospitting and efficiently receives saliva from a donor as the donor spitsinto a large aperture of the funnel at its top end. The funnelterminates at a narrow, generally cylindrical tubular portion suitablefor containing liquids received therein.

A receiving vessel additionally has integrated therewith an outer bodyportion which forms a rigid standing means upon which the system mayrest upright on flat surfaces. This outer body portion may supportadditional structure such as a viewing window and indicia. A receivingvessel may also include an integrated knife element.

A sealing cap has integrated therewith a seal mechanism, piercableliquid reservoir, grip surface, label receiving surface, among others.

When a cap element is coupled to a receiving vessel, the action offorming a seal therewith additionally causes breach to the integrity ofthe liquid reservoir such that the reservoir contents are released intoand mix with matter already in the receiving vessel while at the sametime forming a seal between the receiving vessel and the sealing capsuch that no liquid can escape containment.

An auxiliary element of these systems is also included in some versions.An application-specific shipping container provides two operationalmodes for shipping and delivery of these devices. That is, the shippingcontainer supports containment of a receiving vessel and sealing capheld separate from each other in a ‘decoupled’ state, and additionallyprovides for containment of a receiving vessel and sealing cap in a‘coupled’ state. In a shipping mode characterized as a ‘decoupled’state, the device is shipped to a user/customer. In a shipping modecharacterized as a ‘coupled’ state the system is returned shipped to alaboratory for analysis. Thus this invention additionally contemplatescooperative shipping facility arranged as special-purpose shippingcontainers designed to further support the tasks and objectivesparticular to direct to consumer saliva sample collection.

OBJECTIVES OF THE INVENTION

It is a primary object of this invention to provide saliva samplecollection systems.

It is an object of this invention to provide saliva sample collectionsystems which are easy to operate by untrained users without specialskill.

It is a further object to provide self-contained saliva samplecollection systems which do not leave waste by products after use.

It is an object of this invention to provide saliva sample collectionsystems which cooperate with a dual-mode application specific shippingcontainer.

It is also an objective to provide systems of reduced parts andincreased ease of use for improved reliability.

A better understanding can be had with reference to detailed descriptionof preferred embodiments and with reference to appended drawings.Embodiments presented are particular ways to realize the invention andare not inclusive of all ways possible. Therefore, there may existembodiments that do not deviate from the spirit and scope of thisdisclosure as set forth by appended claims, but do not appear here asspecific examples. It will be appreciated that a great plurality ofalternative versions are possible.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims and drawings where:

FIG. 1 is a cross-section view of a first version of one saliva samplecollection system;

FIGS. 2 and 3 illustrate a cap being coupled to a receiving vessel via athread set to cause a reservoir membrane to be punctured releasing fluidinto the receiving vessel; and,

FIG. 4 presents one version of a dual-mode shipping container system.

PREFERRED EMBODIMENTS OF THE INVENTION

With attention to the appended drawing FIGS. 1-4 and particularlyreference numerals therein, one gains a firm and complete understandingof system apparatus of these teachings.

Specifically, FIG. 1 illustrates in cross-sectional view of two primaryelements in a spatially proximate relationship on a symmetry axis. Areceiving vessel 1 is a complement part to a sealing cap 2—as these arearranged such that their geometries cooperate and include means fortight coupling with respect to each other. The receiving vessel elementincludes an integrated funnel portion 3 with an entrance aperture 4 andelongated cylindrical tubular portion 5 which lies coaxially withrespect to a second cylindrical structure a rigid body 6 includingterminus surface 7, for example an annulus, lying in a plane forming a‘foot’ or ‘base’. At the top of the receiving vessel element at anoutside peripheral edge, a thread set system 8 is formed as a part of acoupling means between the receiving vessel element and the cap element.This coupling may further include a well-designed seating surface 9 tocooperate with an annular flange 10 integrated with the sealing cap toform a liquid tight seal. While preferred versions include those wherethe flange is molded integrally with the cap, other version includethose where pressure fit receiving space holds an ‘O’-ring to thesealing cap interior. When a sealing cap arranged accordingly is coupledwith the receiving vessel, the cap forms a more durable liquid-tightseal with the receiving vessel at the ‘O’-ring and corresponding andcooperating seat. A complementary and cooperating thread set 11 isformed on an inside cylindrical surface of the cap. When a cap sodescribed and receiving vessel similarly so, are brought together androtated about an axis in opposing directions, a liquid tight seal isformed between them as the threads are arranged such that the annularflange is pressure fitted to the seating surface of the receivingvessel. In addition to forming a liquid tight seal between the capelement and the receiving vessel element, the act of bringing these twoelements together via this threaded coupling invokes another importantfunction. A liquid tight reservoir 12 contains therein a special formulawhich operable to stabilize and preserve a biological sample such assaliva. The reservoir is comprised in part of one surface which may bepierced or otherwise compromised such as a thin-film membrane or foil13. When the cap is screwed onto the receiving vessel it advances in anaxial direction towards the receiving vessel. A carefully positionedknife 19 integrated with the receiving vessel is provided to pierce themembrane and cause the liquid therein to leave via gravity. Accordingly,bringing the cap into relation with the receiving vessel assures releaseof the formula from the reservoir and further assures it mixes with thecollected and contained saliva thereby preserving it. The cap elementmay additionally include a knurled outer surface 14 and label receivingsurface 15. The knurled outer surface promotes ease-of-use by permittinggood ergonomic cooperation with the human fingers whereby the cap may betightly coupled to the receiving vessel despite some resisting pressuredue in-part to friction between the thin film membrane and knife andfurther the annular flange and its seat. The label receiving surface isadopted to accept by way of adhesives a label so that these containersmight more easily be marked with identifying information. It isgenerally convenient to associate the contents of a used container witha particular donor and sometimes this is done by way of a label affixedto the cap which does not easily separate therefrom and remains quiteaccessible for every person in the processing chain.

Finally, the receiving vessel element may additionally have integratedtherewith indicia 16 in support to promote ease-of-use. A “fill-line”mark can be included on the tubular cylindrical portion of the receivingvessel or other outside surface of the body. Other indicia may be alsoprovided to similarly promote proper use.

In some preferred versions, a slot may be provided in the body to effecta viewing window 17 by which a user may view more easily the tubularportion which contains sample matter (saliva) being collected. Moreprecisely, to view a ridge 18 formed into the tubular portion whichoperates as a fill-line or fill-limit.

With a clear understanding of each of these systems integrated witheither of the two primary elements, the receiving vessel element or thecap element, a more detailed description of each follows as variousversions are further described. FIGS. 2 and 3 further illustrateimportant aspects of these systems including the coupling between asealing cap 21 and receiving vessel 22. By way of counter-rotation(indicators 23) about a common axis, a cap is screwed on to a receivingvessel to couple therewith. As the cap is turned, the thread set causesthe cap to advance towards (indicated by 24) the receiving vessel alongthe axis. As the reservoir 25 containing preserving fluid thereinadvances to the knife 26 and comes into contact therewith, the thin-film27 is pierced 31 to release the fluid 32 whereby it passes into thereceiving vessel to mix with collected saliva 33. In addition, the capis further advanced such that a liquid-tight seal is formed between theannular flange of the sealing cap 34 and an inside surface 35 of thereceiving vessel which forms a cooperating seat. A pressure betweenthese two elements assures liquid is securely contained within thereceiving vessel for a durable and long-term storage.

One important aspect of these systems relates to use of the apparatusduring a collection step. As the quantity of saliva a required tends tobe more than what might be obtained in a single ‘spit’ action, a donoris required to a repeatedly spit into the funnel aperture. For thisreason, it is desirable that the apparatus can be placed on a flatsurface to rest between spits. To provide for this, a outer tubefashioned as a rigid body is shaped with a base for ‘foot’ portion toassure the vessel is held upright when resting on a table. While thebase may include an opening at its bottom, at least an annular ringwhich lies substantially in a plane provides a resting surface for thesedevices. Some versions may include a flared lip on the body to increasethe surface area of the annulus for improved stability.

The rigid body is sometimes transparent or translucent for an attractive‘clean’ feel and may be formed of molded plastic. In addition, itsoutside surface may be scored or scuffed to provide for an improved gripand handling. As some molded plastics are left quite smooth afterformation, it is sometimes desirable for these apparatus to prepare theoutside surface of the body has a ‘gripping’ surface economicallysuitable for being handled easily by human fingertips.

A reservoir is preferably integrated within an interior cavity portionof the cap element. The reservoir may be formed integrally with the capin a plastic molding step. It is preferably cylindrical in shape andapproximately 1 cm deep. The reservoir may be filled with a preservingfluid by automated machinery, and thereafter the reservoir may be sealedto contain and protect the fluid until it is required for use. Inanticipated systems, a reservoir may contain a specially preparedbonding surface to which a thin-film or foil may be affixed for exampleby adhesives or plastic weld. A thin-film or foil is used to completethe reservoir cell. As these support functionality related to release ofthe fluid from the reservoir at the appropriate time. Namely, when a capelement is coupled to the receiving vessel element, it is desirable toautomatically have the fluid mixed with the saliva. Accordingly, withouttaking any extra steps, measuring, pouring, calculation, et cetera, anunskilled user preserves the saliva sample merely by screwing the cap tothe receiving vessel together.

In one preferred version, the in a preserving fluid contained in thereservoir is colored with a dye agent. This yields a mechanism by whicha user can easily determine that the foil seal was appropriatelycompromised and that the fluid previously contained in the reservoir hasbeen released therefrom and has further mixed with the saliva sample. Insystems where a dye is not used, it has been observed that failure dueto malfunction of the foil piercing system went undetected in the samplesubsequently was spoiled. Another important component of these salivacollection systems includes a special dual-mode shipping container. Asthese systems are specifically configured for use directly by consumers,for example at a consumer's private home, it is advantageous to providefor two-way shipping in a container suitable for same. A box 41 may haveinserted therein a foam core element 42. The shipping containerincluding this foam core element by way of cut-out cavities thereinsupports two discrete shipping modes. When a saliva sample collectiondevice in accordance with this invention is shipped to a customer, it isnecessary that the cap and receiving vessel be held separate to protectthe contents of the fluid reservoir against being released. Accordinglyin this first shipping mode a first cut-out cavity 43 is provided toaccommodate the cap 44 containing the reservoir therein, while a secondcut-out cavity 45 is provided to accommodate the receiving vessel 46.Once inserted accordingly, the cap and receiving vessel are heldisolated spatially thereby maintaining the integrity of the reservoir.After use, and once a cap is tightly coupled with a receiving vessel andfluid has been released from its containment in the reservoir, thecombined cap and receiving vessel 48 may be inserted into anothercut-out cavity 47 provided specifically for the combination such thatthe system including the sample mixed with preserving fluid may bereturn shipped to the laboratory. In this manner, the shipping box isparticularly arranged to cooperate with the objective of releasing thepreserving fluid only after use. Additionally, both shipping modes aresupported by a single container and no waste material remains.

In accordance with each of preferred embodiments of the invention,saliva collection preservation and conveyance systems are provided. Itwill be appreciated that each of the embodiments described include anapparatus and that the apparatus of one preferred embodiment may beslightly different than the apparatus of another embodiment.Accordingly, limitations read in one example should not be carriedforward and implicitly assumed to be part of an alternative example.

One will now fully appreciate how easy-to-use saliva sample collectionsystems and kits may be arranged and configured. Although the presentinvention has been described in considerable detail with clear andconcise language and with reference to certain preferred versionsthereof including best modes anticipated by the inventors, otherversions are possible. Therefore, the spirit and scope of the inventionshould not be limited by the description of the preferred versionscontained therein, but rather by the claims appended hereto.

The invention claimed is:
 1. An apparatus for collection and conveyanceof human saliva including DNA matter, comprising two primary elements: areceiving vessel and a sealing cap; wherein said receiving vesselcomprising a rigid body fashioned as an outer concentric cylinder and aninner cylindrical tubular portion, wherein, said rigid body has a slothole cut therein, the slot hole being operable as a view window wherebya user may view the inner cylindrical tubular portion; said receivingvessel element and sealing cap element each having integrated therewitha complementary mechanical interlocking system forming a liquid-tightseal therebetween when in a coupled state, whereby features of theapparatus are directly integrated with either the receiving vesselelement or the sealing cap element.
 2. The apparatus of claim 1, whereinsaid receiving vessel further includes a ridge formed on saidcylindrical tubular portion, and wherein the ridge and view window arealigned radially and axially whereby a user may easily view the ridgevia said view window.